A randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy.

OBJECTIVE To compare the objective anatomic outcomes after sacral colpopexy performed with cadaveric fascia lata and polypropylene mesh. METHODS Patients undergoing a sacral colpopexy were randomized to receive either fascia lata or polypropylene mesh in a double-blinded fashion. Data were collected at 6 weeks, 3 months, 6 months, and 1 year postoperatively. The main outcome measures were pelvic organ prolapse quantification (POP-Q) system stage and individual POP-Q points over time. Objective anatomic failure was defined as POP-Q stage 2 or more at any point during the follow-up period. Proportions of patients with objective anatomic failure at 1 year in each group were compared using the chi(2) test. Mean POP-Q points and stage at 1 year were compared by using the independent samples t test. RESULTS One hundred patients were randomized to receive either fascia (n = 46) or mesh (n = 54). Of the 89 patients returning for 1-year follow-up, 91% (41/45) of the mesh group and 68% (30/44) of the fascia group were classified as objectively cured (P = .007). We found significant differences between the mesh and fascia groups with respect to the 1-year postoperative comparisons of points Aa, C, and POP-Q stage. There were no differences between the 2 groups with respect to points TVL (total vaginal length), GH (genital hiatus), PB (perineal body), Ap or Bp (2 points along the posterior vaginal wall). CONCLUSIONS Polypropylene mesh was superior to fascia lata in terms of POP-Q points, POP-Q stage, and objective anatomic failure rates. LEVEL OF EVIDENCE I.